Program Manager I
December 8, 2022
Program Manager I
Job ID: req2587
Employee Type: exempt full-time
Division: Clinical Monitoring Research Program
Facility: Frederick: INDUS
Location: 5705 Industry Lane, Frederick, MD 21704 USA
The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.
Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.
PROGRAM DESCRIPTION
Within Leidos Biomedical Research Inc., operator of the Frederick National Laboratory for Cancer Research, the Clinical Monitoring Research Program Directorate (CMRPD) provides high-quality comprehensive and strategic operational support to high-profile domestic and international clinical research initiatives sponsored by the National Cancer Institute (NCI), the National Institute of Allergy and Infectious Diseases (NIAID), the National Institutes of Health (NIH), and several other institutes within NIH. CMRPD's ability to provide rapid responses and high-quality solutions, and to recruit and retain experts with a variety of backgrounds, allows the directorate to facilitate strategic support to the growing clinical research portfolios of NCI, NIAID, and other NIH divisions/offices/centers. CMRPD's support services are aligned with the program's mission to provide comprehensive clinical trials operations and program/project management services to advance scientific clinical research that complies with applicable regulations and guidelines, maintains data integrity, and protects human subjects. CMRPD services include clinical trials monitoring, regulatory affairs support, clinical safety oversight, protocol navigation/protocol development, and programmatic and project management support to facilitate the conduct of more than 400 Phase I, II, and III domestic and international trials annually. These trials investigate the prevention, diagnosis and treatment of cancer, influenza, HIV, infectious diseases and emerging health challenges like Ebola virus and COVID-19, heart, lung, and blood disorders, parasitic infections, and rare and neglected diseases. CMRPD's collaborative approach to clinical research support and the expertise and dedication of staff to the continuation and success of CMRPD's mission has contributed to improving the overall standards of public health on a global scale.
The Clinical Monitoring Research Program Directorate (CMRPD) provides specialized support for initiatives and special projects sponsored by the National Institute of Allergy and Infectious Diseases Division of Clinical Research (DCR). CMRPD is responsible for the management and oversight of NIAID clinical research studies related to COVID-19 and other emerging and re-emerging infectious diseases.
KEY ROLES/RESPONSIBILITIES
CONTINGENT ON FUNDING APPROVAL
BASIC QUALIFICATIONS
To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:
PREFERRED QUALIFICATIONS
Candidates with these desired skills will be given preferential consideration:
Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
#readytowork
Job ID: req2587
Employee Type: exempt full-time
Division: Clinical Monitoring Research Program
Facility: Frederick: INDUS
Location: 5705 Industry Lane, Frederick, MD 21704 USA
The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.
Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.
PROGRAM DESCRIPTION
Within Leidos Biomedical Research Inc., operator of the Frederick National Laboratory for Cancer Research, the Clinical Monitoring Research Program Directorate (CMRPD) provides high-quality comprehensive and strategic operational support to high-profile domestic and international clinical research initiatives sponsored by the National Cancer Institute (NCI), the National Institute of Allergy and Infectious Diseases (NIAID), the National Institutes of Health (NIH), and several other institutes within NIH. CMRPD's ability to provide rapid responses and high-quality solutions, and to recruit and retain experts with a variety of backgrounds, allows the directorate to facilitate strategic support to the growing clinical research portfolios of NCI, NIAID, and other NIH divisions/offices/centers. CMRPD's support services are aligned with the program's mission to provide comprehensive clinical trials operations and program/project management services to advance scientific clinical research that complies with applicable regulations and guidelines, maintains data integrity, and protects human subjects. CMRPD services include clinical trials monitoring, regulatory affairs support, clinical safety oversight, protocol navigation/protocol development, and programmatic and project management support to facilitate the conduct of more than 400 Phase I, II, and III domestic and international trials annually. These trials investigate the prevention, diagnosis and treatment of cancer, influenza, HIV, infectious diseases and emerging health challenges like Ebola virus and COVID-19, heart, lung, and blood disorders, parasitic infections, and rare and neglected diseases. CMRPD's collaborative approach to clinical research support and the expertise and dedication of staff to the continuation and success of CMRPD's mission has contributed to improving the overall standards of public health on a global scale.
The Clinical Monitoring Research Program Directorate (CMRPD) provides specialized support for initiatives and special projects sponsored by the National Institute of Allergy and Infectious Diseases Division of Clinical Research (DCR). CMRPD is responsible for the management and oversight of NIAID clinical research studies related to COVID-19 and other emerging and re-emerging infectious diseases.
KEY ROLES/RESPONSIBILITIES
CONTINGENT ON FUNDING APPROVAL
- Provides programmatic support to the NIAID Division of Clinical Research (DCR) research portfolio and CMRPD's research response efforts
- Serves as a liaison for stakeholder communications in support of high-profile projects
- Interfaces with government officials, research partners, administrative officers, program specialists, panel members, and CMRPD staff members
- Reviews and edits public facing guidelines and communications
- Coordinates logistical needs for virtual and in-person meetings, draft agendas when necessary, assists with scheduling meetings and distributing meeting materials and taking meeting minutes
- Documents and tracks action items for panel leaders, organizes task timelines and due dates
- Assists with version control of document revisions
- Categorizes and organizes relevant project documents
- Facilitates cloud content management and file sharing services
- Analyzes, summarizes, and tracks survey responses and other project-related data
- Performs data visualization tasks utilizing excel or other software
- Assists with the creation of standard operating procedures for the documentation of treatment guideline development processes
- Conducts literature searches
- Ensures timely response, review, and submittal of customer and project-level inquiries
- Creates and implements detailed administrative operational project plans
- Performs assignments independently but may be subject to supervisory or appropriate project staff oversight as needed
- Composes and edits various program and scientific communications and documents, including spreadsheets, presentations, and other communications
- May assists in the preparation of reports, including writing of semi-annual and annual reports, quarterly reports, and other project report requirements
- May provide logistical operation oversight and support for the life cycle of project procurements
- May travel domestically (5%)
- This position is located in Frederick, Maryland
BASIC QUALIFICATIONS
To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:
- Possession of a bachelor's degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) in health sciences, clinical research, or a related field, or four (4) years related experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency
- In addition to educational requirements, no additional experience is required
- Progressively responsible experience must demonstrate increased independence and overall responsibility for multi-faceted projects
- Ability to work in a fast-paced clinical research setting, both independently and within a team
- Effective communication and strong organization skills
- Excellent writing and editing skills required
- Demonstrated knowledge of infectious disease research and scientific terminology
- Proficient in Microsoft Word, Excel, PowerPoint and with cloud content platforms
- Ability to obtain and maintain a security clearance
PREFERRED QUALIFICATIONS
Candidates with these desired skills will be given preferential consideration:
- Master's degree preferred
- Excellent research, problem-solving, public speaking, writing, and interpersonal communication skills
- Experience managing public health or research programs with complex and diverse scientific collaborations
Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
#readytowork